Kornimate/medical-research-clean huggingface dataset:
the effect of foeniculum vulgare ironing on gastrointestinal recovery after colorectal resection

Conditions: Colorectal Surgery; Foeniculum; Ileus

Summary: chinese medicine ironing using foeniculum vulgare has been applied in some departments to promote bowel function recovery, but the efficacy of ironing therapy remains uncertain after colorectal resection surgery.

postoperative ileus is one of the most common complications after abdominal surgery. it refers to obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal or nonabdominal surgery. when the expected period of gastrointestinal recovery time extends beyond what is acceptable, the patient is diagnosed as having a "pathologic" postoperative ileus (poi), which leads to patient discomfort, dissatisfaction, prolonged hospitalization and increased medical expenses. the incidence of poi is about 17%\~24% after abdominal surgery. chinese medicine ironing using foeniculum vulgare has been applied in some departments to promote gastrointestinal function recovery as a empiric therapy. however, the definite efficacy of foeniculum vulgare ironing therapy（fit）is uncertain after colorectal resection surgery and whether fit can reduce the incidence of poi remains unkonown.

Eligibility criteria:
inclusion criteria: 1. age: 18 \~ 85 years old; sex is not limited. 2. selective operation of colorectal partial resection. 3. participants are volunteered to participate in this study, sign informed consent, and cooperated with follow-up. exclusion criteria: 1. emergency surgery. 2. pregnant or lactating women. 3. asa class 4 or 5 patients. 4. patients with severe abdominal adhesions, which would cost more than 30 minutes to release. patients with abdominal cocoon disease. 5. patients with peritoneal metastasis or inflammatory bowel disease. 6. patients undergoing enterostomy or total colectomy. 7. patients simultaneously enrolled in any other competing clinical study.

Keywords: colorectal surgery foeniculum ileus
comparison of bimatoprost sustained release (sr) to selective laser trabeculoplasty (slt) in adults with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate the intraocular pressure (iop)-lowering effect and safety of bimatoprost sr compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical iop-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).


Eligibility criteria:
inclusion criteria: * diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require iop lowering treatment. * in the investigator's opinion, patient's iop is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence). * in the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with slt monotherapy. exclusion criteria: * history of previous laser trabeculoplasty * history or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[iol\], sulcus iol, aphakia, etc) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss\], substantial iris trauma, etc) or history of phakic iol insertion for refractive error correction * intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment * previous use of commercially available bimatoprost sr; concurrent enrollment in another allergan bimatoprost sr study; or previous enrollment in which an implant was received.
investigation of potential retinal toxicity associated with hair dye products containing ppd type aromatic amines

Conditions: MEK Inhibitor-Associated Serous Retinopathy

Summary: hair dye products could induce minimal forms of mekar retinopathies (mitogen-activated extracellular signal-regulated kinase - inhibitors associated retinopathies). these minimal forms of mekar are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. the aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by mekar retinopathies can be induced.


Eligibility criteria:
inclusion criteria: * hair dye up to one month before the inclusion * hair dye product containing aromatic amines exclusion criteria: * pregnant or lactating woman * retinal pathology already known, or central serous choroiditis

Keywords: mek inhibitor-associated serous retinopathy hair dye aromatic amines
comparing the reliability of expressed prostatic secretion (eps) and post massage urine (pmu) for the prediction of prostate cancer biopsy outcome

Conditions: Conditions Influencing Health Status; Healthy; Prostate Cancer

Summary: this randomized pilot phase i trial studies the best way, either expressed prostatic secretion (eps) or post massage urine (pmu) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. studying samples of urine in the laboratory may help doctors detect prostate cancer. it is not yet known whether eps or pmu biomarkers are more effective in predicting prostate biopsy results

objectives: i. to determine which non-invasive test for prostate cancer, eps or pmu, is a better predictor of prostate cancer biopsy result. (part i) ii. to determine whether standardized testing for transmembrane protease, serine 2 (tmprss2):erg types iii and vi is superior to testing for tmprss2:erg type iii in predicting prostate biopsy outcome. (part i) iii. to expand the sample size utilizing the best tmprss2:erg test and the best specimen type as determined in objective i and ii in order to estimate with reasonable accuracy the positive predictive value (ppv) and negative predictive value (npv) for each test. (part ii) iv. to expand the biomarker set, to include prostate cancer antigen 3 (pca3)-ribonucleic acid (rna), d-glyceraldehyde-3-phosphate dehydrogenase (gadph)-rna, prostate-specific antigen (psa)-rna, and deoxyribonucleic acid (dna) methylation levels at glutathione s-transferase pi (gstp1), adenomatous polyposis coli (apc), retinoic acid receptor beta (rarb), mitochondrial dna (mt-dna) deletions and ras association (ralgds/af-6) domain family 1 (rassf1), so as to develop an extensive data set for use in multivariate analysis. (part ii) v. use multivariate analysis to determine which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (serum psa and digital rectal examination \[dre\]). (part ii) vi. estimate ppv and npvs from this analysis and compare them to the standard assay's performance. (part ii) outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive digital rectal palpation and then void a spontaneous urine sample for pmu analysis. patients then undergo a prostate biopsy. arm ii: patients receive dre with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of eps. patients then undergo a prostate biopsy.

Eligibility criteria:
inclusion criteria: * all men who will be undergoing transrectal ultrasound of the prostate (trusp) with biopsy in the department of urology or participating urology clinics for the evaluation of prostate cancer exclusion criteria: * men with a previous diagnosis of prostate cancer * men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious dre or psa * men with a prior diagnosis of cancer \< 5 years ago, excluding basal cell carcinoma and/or squamous cell carcinoma

Keywords: health status unknown healthy,no evidence of disease
lgx818 for patients with brafv600 mutated tumors

Conditions: Solid Tumor; Hematologic Malignancies

Summary: the purpose of this signal seeking study is to determine whether treatment with lgx818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study


Eligibility criteria:
inclusion criteria * patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of melanoma and colorectal cancer (crc)) or hematologic malignancies and is in need of treatment because of progression or relapse. * patient's tumor has been evaluated and pre-identified as having a tumor with a brafv600 mutation at a clia certified laboratory. * patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission. * patient must have progressive and measurable disease per recist 1.1. or other appropriate hematological response criteria. * patient has an eastern cooperative oncology group (ecog) performance status ≤ 1 exclusion criteria: * patient has received prior treatment with lgx818. * patients with central nerve system (cns) metastasis or leptomeningeal carcinomatosis. * patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-c) prior to starting study drug. * patients with acute or chronic pancreatitis. * patients with impaired cardiac function or clinically significant cardiac diseases. * patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
study evaluating the efficacy of thick shell mussel lipid extract in chinese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: previous study found that lipid extract from hard-shelled mussel (hmle) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. in the present study, hmle was processed to capsules under strict food safety supervision and patients with active rheumatoid arthritis (ra）were selected to examine whether supplementation with hmle could improve clinical and laboratory parameters of disease activity. the validated disease activity score that include 28 joint counts and esr (das28) and validated clinical disease activity index (cdai) were primary outcome measure. laboratory parameters including il-1β, il-6, il-10, tnf-α,pge2 and cox-2 were also measured to explore the mechanisms.

in this randomized controlled design, patients continued receiving background medications (slow-acting anti-rheumatic drugs and non-steroidal anti-inflammatory drugs) without change and were assigned to two groups. the first group (g1) received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter. the second group (g2) received corn oil capsules (400mg corn oil per capsule) according to the same regimen. all patients were asked to keep a 7-day food diary before intervention and during wk 12. dietary energy and nutrient intake of each subject during the preexperimental and study period were assessed from the dietary records by using "diet analysis" software (cao aihong, taiyuan, china). all the enrolled patients visited zhejiang sir run run shaw hospital in the morning following an overnight fast at baseline and 3-month intervals, and underwent anthropometric measurements including height, body weight, waist circumference, hip circumference, heart rate and blood pressure. then clinical evaluations were performed during face-to-face interview by a professional attending doctor and ten milliliter of peripheral venous blood was drawn. serum and erythrocyte samples were also promptly processed and frozen at -80℃ until analysis.

Eligibility criteria:
inclusion criteria: * according to the american college of rheumatology criteria, patients from zhejiang province with active ra were included in this study and all participants were chinese. patients had at least 3 swollen joints and 6 tender joints or had an erythrocyte sedimentation rate (esr) of \>28mm/hr or morning stiffness of at least 45 min were classified as with active disease. exclusion criteria: * subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure.

Keywords: anti-inflammation, rheumatoid arthritis, thick shell mussel lipid extract, chinese
evaluate safety & efficacy of condroflex in subjects with oa

Conditions: Treatment; Osteoarthritis; Elderly

Summary: primary objective: to compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire womac (western ontario and mcmaster universities arthritis index), achieved with condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee oa and not exposed to prior treatment with the products under investigation.

to have osteoarthritis degree 2 or 3 / to be capable to consent

Eligibility criteria:
inclusion criteria: * to have knee osteoarthritis degree 2 or 3 * to be capable to consent exclusion criteria: * previous drug treatment * concomitant diseases * concomitant drugs

Keywords: chondroitin glucosamine osteoarthritis
a comparison of prasugrel at pci or time of diagnosis of non-st elevation myocardial infarction

Conditions: Acute Coronary Syndromes

Summary: the purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-st-elevation myocardial infarction (nstemi) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (pci).

this trial consists of two arms. one arm is a non pre-treatment arm. participants in this arm will receive placebo immediately after nstemi diagnosis and prior to the diagnostic coronary angiography. a 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to pci. subsequently, participants will receive daily maintenance doses of prasugrel until day 30. participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. all others will receive a 10 mg oral daily maintenance dose for 30 days. the other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after nstemi diagnosis and prior to diagnostic coronary angiography. the remainder of the loading dose (30 mg) will be administered when the participants are proceeding to pci. subsequently, participants will receive daily maintenance doses of prasugrel until day 30. participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. all others will receive a 10 mg oral daily maintenance dose for 30 days.

Eligibility criteria:
inclusion criteria: * have acute coronary syndrome consisting of non-st-segment elevation with elevated troponin * scheduled for coronary angiography/pci greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization * must be eligible for treatment with prasugrel, aspirin (asa), and a glycoprotein iib/iiia receptor (gpiib/iiia) inhibitor as per respective labels * may be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel * must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital exclusion criteria: * present with st-segment elevation myocardial infarction (stemi) at the time of entry or randomization * have cardiogenic shock * have refractory ventricular arrhythmias * have new york heart association (nyha) class iv congestive heart failure (chf) * have had cardiac arrest within 1 week of entry or randomization into the study

Keywords: acute coronary syndromes heart disease percutaneous coronary intervention p2y12 nstemi
effect of ghrelin on glucose metabolism after bariatric surgery

Conditions: Obesity

Summary: the purpose of this study is to determine if the altered nutrient exposure to the gi tract after bariatric surgery reveals a negative incretin effect of ghrelin.


Eligibility criteria:
inclusion criteria: * bmi ≥ 35 kg/m2 * age 21-65 years * weight ≤ 200 kg exclusion criteria: * type 2 or type 1 diabetes * medications that alter insulin sensitivity or carbohydrate metabolism * positive pregnancy test * known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. chronic ulcerative colitis, crohn's disease, celiac sprue) * prior gastric or intestinal surgery or pancreas resection * history of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension * history of chronic kidney disease or renal insufficiency; creatinine \> 1.8 mg/dl. * history of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; ast and/or alt \> 2x the upper limit of normal. * abnormal ecg

Keywords: obesity bariatric surgery
dalteparin versus unfractionated heparin in patients with acute coronary syndrome

Conditions: Angina, Unstable; Myocardial Infarction

Summary: to compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non st elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)

the study was prematurely discontinued on november 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. there were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * patients more than 18 years * ischemic pain of more than 10 minutes within 24 hours before enrollment * at least two of the following three risk factors : age more than 60 years ( or more than 50 in case of diabetics), raised cardiac enzyme levels, abnormal ecg findings exclusion criteria: * contraindications to use of anticoagulants * active bleeding or abnormal coagulation tests * ischemic stroke within last 6 months or hemorrhagic stroke * lumbar or spinal puncture within last 48 hours * s creatinine levels more than 2

Keywords: non-st elevation acute coronary syndromes coronary interventions
relapse patterns in female cocaine users - 4

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in female cocaine users.

the objectives of this study were to determine the most important antecedent factors in relapse episodes and difference in the use of coping skills between relapses and "close calls"

Eligibility criteria:
inclusion criteria: female, cocaine abuse or dependency by scis, at least 7 days of current abstinence, cocaine use of 8 out of 30 days prior to current abstinence, ages 18-60. exclusion criteria: inability to participate in a 90 day longitudinal study

Keywords: cocaine-related disorders
a safety, tolerability, pharmacokinetic and pharmacodynamic study of ace-031 in healthy postmenopausal women

Conditions: Muscular Atrophy

Summary: the purpose of this study is to establish safe dose levels of ace-031 in healthy postmenopausal women following multiple dose administration. this study will also evaluate if ace-031 has an effect on muscle.


Eligibility criteria:
inclusion criteria: * postmenopausal * body mass index (bmi) of ≥ 18.5 to \< 32. exclusion criteria: * history of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas * history of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. * history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening. * surgery within 3 months prior to day 1 (other than minor cosmetic or dental procedures). * fever or symptomatic viral or bacterial infection within 7 days prior to day 1. * donation or significant loss of blood within 2 months prior to day 1. * hormone replacement therapy within 3 months prior to day 1. * treatment with erythropoiesis stimulating agents (epogen, procrit, aranesp, etc) within 2 months prior to day 1. * systemic glucocorticoid therapy within 6 months prior to day 1. * treatment with another investigational drug or approved therapy for investigational use within 1 month prior to day 1. * previous treatment with ace-031.